Drugs
In a study funded by FDA, academic and FDA researchers who surveyed doctors about their experiences with Risk Evaluation and Mitigation Strategies (REMS) for eight REMS-covered drugs found that most doctors said the REMS certification process provided useful information about the drugs but wanted more information on their benefits
Devices
FDA has cleared an X-trodes 510(k) for its X-trodes Smart Skin device, a wireless wearable technology for electrophysiological monitoring. The device comprises customizable dry-printed multi-modal electrode patches that are intended to monitor a range of biopotential signals from anywhere on the body to acquire EEG
Drugs
FDA has granted Harmony Biosciences Holdings an orphan drug designation for pitolisant and its use in treating Prader-Willi syndrome (PWS). The company says about 20,000 people in the U.S. have PWS, and the majority experience behavioral symptoms and more than half suffer from excessive daytime sleepiness. The
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) in combination with standard-of-care chemotherapy (carboplatin and paclitaxel), followed by Keytruda as a single agent for treating patients with primary advanced or recurrent endometrial carcinoma. The agency has set a user fee review action target
Drugs
ARS Pharmaceuticals says it will submit in the second quarter its nasal allergen challenge study data as part of a response to a 9/2023 FDA complete response letter on an NDA for neffy (epinephrine nasal spray) for treating Type 1 allergic reactions, including anaphylaxis, in adults and some children.
Drugs
A 9/4-9/8/2023 FDA inspection at Sichuan Deebio Pharmaceutical Co. Ltd., in Sichuan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A 2/14 Warning Letter says specific deviations were: * failing to follow and document laboratory controls at the
Drugs
FDA has placed a clinical hold on a RAPT Therapeutics Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis and a Phase 2a trial in asthma. The action was based on a serious adverse event — liver failure — in one patient in the atopic dermatitis trial, according to the company. The
Drugs
An online Clinical Leader guest column raises the question of why the drug industry is resisting quality management changes that FDA so clearly supports. PDC Pharma Strategy CEO Penelope Przekop, a quality management expert, says that at a recent meeting of agency representatives and stakeholders to discuss the challenges and
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 12/22 notice for its “Master Protocols for Drug and Biological Product Development” draft guidance. The extension is based on requests from stakeholders requesting additional time to submit comments. To view the notice, click here.
Biologics
FDA has granted accelerated approval to Iovance Biotherapeutics for Amtagvi, a cellular therapy indicated for treating adult patients melanoma that is unable to be removed with surgery (unresectable) or has spread to other parts of the body (metastatic) that previously has been treated with other therapies (a PD-1 blocking
Biologics
FDA has accepted for priority review a Sarepta Therapeutics supplemental BLA for Elevidys (delandistrogene moxeparvovec-rokl) to convert the earlier accelerated approval to a traditional approval, and to expand the labeled indication for treating Duchenne muscular dystrophy (DMD) patients with a confirmed mutation in the DMD gene. The agency has
Biologics
FDA has approved a Novartis supplemental BLA for Xolair (omalizumab) for reducing allergic reactions, including anaphylaxis, that may occur with accidental exposure to one or more foods in adult and pediatric patients aged one year and older with Immunoglobulin E (IgE)-mediated food allergy. Approval is based on data from
FDA Policy/General
Federal Register notice: FDA is amending a 12/12/2023 notice requesting nominations for voting members to serve on CDER’s Genetic Metabolic Diseases Advisory Committee. The amendment says nominations received on or before 3/12 will be given first consideration for membership on the committee. To view the notice,
Drugs
Gilead Sciences says it has paused enrollment globally in its magrolimab solid tumor studies and FDA subsequently requested a partial clinical hold on these as well. The hold is in addition to the previously announced full clinical hold on all magrolimab studies in acute myeloid leukemia and myelodysplastic syndromes requested
Devices
After serving 14 years at FDA, CDRH Office of Product Evaluation and Quality (OPEQ) director William Maisel is set to retire this spring, according to an agency email to MedTech Dive. OPEQ is responsible for the program areas for approving and clearing medical devices, such as 510(k)s, PMAs,
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, the design of bioequivalence studies to support ANDAs. To view the notice, click here.
Drugs
FDA has published 29 new and 33 revised product-specific guidances (PSGs) with recommendations for developing generic drugs and generating evidence to support ANDA approvals. The agency will receive public comments before finalizing the guidances. Some 50 of the PSGs are for products with no approved ANDAs, including 27 complex
Biologics
Speaking on 2/14 at the National Press Club, FDA commissioner Robert Califf challenged journalists to “continue striving for approaches that benefit public health in the best possible manner.” Saying he wanted to bring some Valentine’s Day “tough love” to the audience, Califf spoke on his pressing theme of
FDA Policy/General
Senators Dick Durbin (D-IL) and Mike Braun (R-IN) are calling on FDA to “take swift action to update its enforcement tools to reflect the current platforms and methods used to promote prescription drugs and biologics, and to prioritize the protection of children from harmful and inaccurate medical advice.
Drugs
The CDER Drug Safety Priorities report for FY 2023 “features the many ways in which CDER continued to be involved in promoting and protecting public health, as well as ongoing activities to address the national drug overdose crisis.” The report says the Center’s efforts included strategies to address the
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA virtual meeting on advancing the development of therapeutics through rare disease patient community engagement “provided a critical forum to discuss best practices and opportunities for engaging with rare disease patients and other key stakeholders throughout the rare disease drug development
Drugs
FDA is increasing its educational outreach to decrease public hesitancy with biosimilar usage which may be caused by lack of experience with the products or a lack of understanding of what biosimilars are and how the agency reviews and approves them. CDER Office of Therapeutic Biologics and Biosimilars (OTBB) has